Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

June 25, 2008 updated by: The George Institute

A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage

The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain.

Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown.

The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death & disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2138
        • Concord Hospital
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • Newcastle, New South Wales, Australia, 2310
        • John Hunter Hospital
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3181
        • Alfred Hospital
      • Melbourne, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's hospital
      • Melbourne, Victoria, Australia
        • Monash Medical Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • China
      • Beijing, China, 100034
        • Regional Coordinating Centre: Peking University First Hospital
      • Beijing, China
        • Hospitals in China, c/o The George Institute China
      • Shanghai, China, 200025
        • Regional Coordinating Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
  • New Zealand
      • Auckland, New Zealand
        • North Shore Hospital
      • Christchurch, New Zealand
        • Christchurch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years or above
  • Acute stroke due to spontaneous ICH confirmed by clinical history & CT scan
  • At least 2 systolic BP measurements of >/=150mmHg and </=220mmHg, recorded 2 or more minutes apart
  • Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
  • Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit

Exclusion Criteria:

  • Known definite contraindication to an intensive BP lowering regimen
  • Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm
  • Definite evidence that the ICH is secondary to a structural abnormality in the brain
  • Previous ischaemic stroke within 30 days
  • A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
  • Known advanced dementia or significant pre-stroke disability
  • Concomitant medical illness that would interfere with outcome assessments and follow up
  • Already booked for surgical evacuation of haematoma
  • Previous participation in this trial or current participation in another investigational drug trial
  • A high likelihood that the patient will not adhere to the study treatment and follow up regimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months
Time Frame: 24 and 72 hours, 1 and 3 months
24 and 72 hours, 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: Craig Anderson, PhD, The George Institute
  • Principal Investigator: Bruce Neal, PhD, The George Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

June 26, 2008

Last Update Submitted That Met QC Criteria

June 25, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDA1INTERACT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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